Scientist I - Ostomy / Continence Care

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring.

Position Overview:

A Scientist I in the Physical Testing Department supports the product development process for medical devices. Research Assistants should have a good understanding of the importance of physical testing in ensuring the safety, efficacy, and quality of medical devices. Scientists are responsible for conducting various tests and experiments to assess the physical properties of medical devices. Scientists will generate, document and analyse data in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP). Scientists should be detail-oriented, able to work on multiple projects and adapt to changes, with good problem-solving skills and strong communication are essential.

Key responsibilities:

• Working within a controlled ISO 13485 and ISO 9001 laboratory quality system and in accordance with GxP procedures.
• Design, plan and execute Physical Testing in support of R&D activities and base business projects in accordance with applicable procedures and guidelines.
• Development and validation of new Physical Testing methods.
• Estimating the resources and time required to conduct an experiment and monitoring performance to ensure targets are met.
• Author validation protocols, reports and technical documents for medical devices/pharmaceutical products.
• Perform basic statistical analysis of test data.
• Prepare and present internal presentations to present findings of the laboratory.
• Effective organisation of assigned workload; ensures integrity of all data generated and timely/accurate provision of results to GLP standards.
• Accurate recording and analysis of laboratory data in accordance with good documentation practices.
• Perform detailed laboratory investigations to determine the root cause analysis of atypical and out of specification results, apply corrective and preventative actions and author concise investigation reports.
• Assist in laboratory test method/procedural revisions.
• Ensures laboratory compliance with cGMP regulations and SOP’s/TD’s.
• Involvement in change control activities and associated actions.
• Support laboratory daily activities such as laboratory housekeeping, equipment maintenance and calibration, solution preparation, consumable stock replenishment, shipping samples, scanning documentation, logging of samples etc.

Skills & Experience:

• Graduate/entry level. Familiarity with safe working in a laboratory environment. Experience in a working laboratory environment, within Medical Devices / Pharmaceutical Industry is preferred.
• Good written and verbal communication skills.
• Good working knowledge of Microsoft Office, specifically Word and Excel.
• Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulation.
• A detailed understanding of common statistical analysis and experience with MiniTab desirable.

Qualifications/Education:

• Bachelor’s Degree in a relevant science-related discipline, i.e., biological sciences.

Dimensions:

• Team Reports to Team Lead.

Principal Contacts & Purpose of Contact:

• Scientific and Technology laboratory members – collaborative work, problem solving, data discussion.
• Project team representatives – collaborative work, problem solving, delivery of results.

Travel Requirements:

• Little to no.

Working Conditions:

This position is based in Deeside (UK) working within an office and laboratory environment. This is an onsite position with the opportunity to occasionally remote work as and when agreed in advance with their manager. Working in a laboratory environment with exposure to biological agents, chemicals and reagents – Training will be provided. Competent in the disposal of chemicals and reagents in accordance with site and local environmental procedures – Training will be provided. Health and Safety at Work etc. Act 1974. The Management of Health and Safety at Work Regulations 1999.

Special Factors:

Flexibility of task management and working laboratory environment is essential due to continually changing priorities. Convatec is a multi-national company therefore some flexibility in hours is required due to working in an international company with colleagues in different time zones.

Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone. This is work that’ll move you.